CN103418053A - Individualized insulin treatment pump and basic infusion rate optimization method thereof - Google Patents
Individualized insulin treatment pump and basic infusion rate optimization method thereof Download PDFInfo
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Abstract
The invention relates to an individualized insulin treatment pump (CSII) assisted by a CGMS. The individualized insulin treatment pump comprises an insulin pump body, a communication module, a data processing module and an infusion actuator. The insulin pump body receives a treatment scheme obtained by the data processing module and controls the infusion actuator to infuse insulin according to the treatment scheme. The communication module obtains data from the CGMS and the insulin pump body so as to allow the data processing module to form the treatment scheme. The invention further relates to a basic infusion rate optimization method based on the insulin treatment pump. By the adoption of the individualized insulin treatment pump and the basic infusion rate optimization method of the individualized insulin treatment pump, a model can be formed according to real-time feedback blood glucose data of each patient, and the basic infusion amount is judged and optimized by stimulating and adjusting the basic infusion rate of the insulin.
Description
Technical field
The present invention relates to a kind of insulinize pump, be specifically related to a kind of individual insulin treatment pump, relate to a kind of infusion amount optimization method that is applicable to insulinize pump field simultaneously, especially a kind ofly can and optimize the method for insulin basis infusion amount according to real-time monitored patient blood glucose level data.
Background technology
● insulinize pump (CSII) general introduction
The insulinize pump is the insulin input equipment that adopts the artificial intelligence to control, and by continuing the mode of h inf insulin, thereby the physiological secretion pattern of simulation insulin is controlled a kind of insulinogenic therapeutic method of hyperglycemia.
Under physiological status, insulin secretion can roughly be divided into two parts by the relation with having meal: the one, do not rely on the continuous micro secretion of dining, i.e. and Basal insulin secretion, now insulin is secreted with interval 8~13min impulse form; The 2nd, stimulate by hyperglycemia after having meal a large amount of insulin secretions that cause.
For simulation physiological insulin secretion, attempt the CSII method as far back as the sixties in 20th century.At present, insulin pump is controlled by the artificial intelligence, in adjustable pulsed h inf mode, and Basal insulin secretion in analogue body; Simultaneously at table, set pre-meal insulin and infusion pattern to control post-prandial glycemia according to food species and total amount.
The use of insulin pump is existing more than 20 years history in the world.The critical role of intensive insulin therapy in treating diabetes and complication control established in the announcement of DCCT result of study, and the clinical evidence of high-quality also is provided for the clinical practice of insulin pump.This studies confirm that, with injection of insulin repeatedly, compares, and insulin pump can more effectively be controlled the level of glycolated hemoglobin, has also improved patient's quality of life simultaneously.After the issue of DCCT result of study, the insulin pump consumption of U.S.'s diabetics rises significantly.2005, U.S.'s insulin pump user reached 278000 people.Type 1 diabetes (T1DM) accounts for the overwhelming majority in the insulin pump user.
The insulinize pump has following features:
(1) more be conducive to glycemic control
Comprise steady control blood glucose, minimizing blood glucose fluctuation, the body weight of avoiding excess dosage use insulin to cause increase, obviously reduce the glycemic control of the risk of hypoglycemia generation, the variation that reduces absorption of insulin, reinforcement diabetes peri-operation period etc.
(2) improve patients ' life quality
The use of insulin pump can improve the compliance of patient to treatment, reduces painful and inconvenient that the multiple subcutaneous injections insulin brings to diabetics; Increase the degree of freedom of diabetics feed, motion; Improve patient oneself Blood sugar management ability; Alleviate the diabetics psychological burden.
● the dosage of insulinize pump
Due to the blood glucose in human body and insulin level in the homeostasis process in continuous variation, and be subject to the impact of many factors, about the dosage of how to confirm insulinize pump, be one of research emphasis always.The infusion scheme that 2009 editions Chinese insulin pump in treatment guides are recommended may be summarized to be: at first should determine predose and be assigned to basic infusion amount and before the meal in heavy dose according to patient's diabetes typing, blood sugar level and body weight situation, then determine and supplement heavy dose of and proofread and correct heavy dose of with Comprehensive Control patient blood glucose according to patient's practical situation.Wherein, basic infusion amount refers to and maintains the required amount of insulin of body basis metabolism of blood glucose, can regulate the effect of basic infusion amount for the patient by regulating basic infusion rate and corresponding time period.The basis infusion rate refers to that insulin pump provides the speed of basal insulin, generally with insulin dosage (U)/h, means, its set model is more, can be set to according to the needs of glycemic control one or more time periods, clinically mostly is divided into 3~6 time periods.T2DM patient, the generally more segmentations of T1DM needs of patients employing relatively.In T2DM patient, the so-called fragility DM patient's that the blood glucose fluctuation value is larger segmentation method is often variant with general patient.
In the insulin pump specific implementation process, how heavy dose, supplementary time period heavy dose of, that correction is heavy dose of and basic infusion rate is taked are set according to standard or experience before the meal, therefore basic infusion amount is only the content that the user mainly regulates.And; because Most patients can't be worn the insulinize pump all the life; so clinically usually can be after it to use a period of time insulinize pump, the basic infusion amount that main basis can obtain optimum curative effect is determined the dosage that should take when it uses injection of insulin.
Owing to existing huge individual variation between the patient, make and often be difficult to clinically to determine the most applicable patient's basic infusion amount, thereby realize the Regulation of blood glucose of individuation.Yet current rare scholar or researcher are noticed this point and are proposed to meet the solution of clinical manipulation reality.For example, Chinese patent CN101254322A discloses a kind of bolus insulin fully-automatic intelligent infusion methods and device based on Model Predictive Control in 2008-09-03, under dynamic blood sugar monitoring system (CGMS) is supported, detect online diet the initial bolus insulin of infusion by strong tracking filter, therefore its main focus is heavy dose before the meal.Yet, owing to considering the risk of hypoglycemia that may cause, the bolus insulin dosage automatically calculated is likely unsafe for the user.And for example, Chinese patent CN102500013A discloses a kind of Intelligent portable insulin theraputic pump and its control model in 2012-06-20, and it follows the tracks of change of blood sugar amount infusion of insulin treatment diabetes by dynamic monitoring user's blood sugar level.The infusion pump of this closed loop is controlled model and is reckoned without the patient at presumable violent blood glucose fluctuation after the meal, and what adopt due to it is historical irrelevant regulate and control method, so its regulation and control result can't reflect patient's characteristic itself, can't remove insulin pump medication afterwards for instructing.
Therefore, need a kind of Real-time Feedback blood glucose level data that can be based on patient self badly, optimize the apparatus and method of basic infusion rate by data modeling and emulation.The present invention is in order to adapt to such demand, and for the deficiency in existing insulinize pump and dose determination process thereof, the dynamic blood sugar monitoring system (CGMS) of take is developed as its auxiliary device.Below CGMS is done to concise and to the point analysis, be convenient to the summary of the invention of back is done to deeply explanation.
● dynamic blood sugar monitoring system (CGMS)
The Dynamic Blood Glucose Monitoring instrument is by continuing the subcutaneous sugared sensor of imbedding, the omnidistance glucose level that records continuously intercellular fluid, the change of blood sugar of reflection.In patient's daily life, the blood glucose value of every day is recorded continuously, and downloads in computer, makes blood glucose figure, for clinical, analyzed and diagnoses.Can fully understand glucose fluctuation type by dynamic glucometer monitoring result doctor, glycemic control and treating diabetes are of great importance.
It is generally acknowledged at present, when the doctor has abundant and professional Clinical Experience, the use in conjunction of the external open cycle system of two C consisted of CGMS and CSII can help it to instruct the careful adjusting of insulin pump dosage by CGMS dynamic glucose collection of illustrative plates, reaches perfect glycemic control.
Summary of the invention
Above-mentioned deficiency for prior art, according to embodiments of the invention, be desirable to provide a kind of individual insulin treatment pump (CSII) that dynamic blood sugar monitoring system (CGMS) is auxiliary device of take, thereby Real-time Feedback blood glucose level data formation model that can be based on each patient self, and pass judgment on and optimize its basic infusion rate by the basic infusion rate that insulin is adjusted in simulation.In addition, the present invention it would also be desirable to provide a kind of method that realizes optimizing basic infusion rate based on described insulinize pump, and the basic infusion rate of adjusting insulin by simulation is passed judgment on and optimized its basic infusion amount.
According to embodiment, individual insulin treatment pump provided by the invention comprises insulin pump body, communication module, data processing module and infusion executor, described insulin pump body is accepted the therapeutic scheme that described data processing module draws, and according to the described infusion executor of control infusion of insulin; Described communication module forms therapeutic scheme from dynamic blood sugar monitoring system CGMS and described insulin pump ontology acquisition data for described data processing module.
According to an embodiment, in the aforementioned individual insulin treatment pump of the present invention, described data processing module comprises data storage cell, algorithm unit and simulation unit, wherein: described data storage cell storage comprises relevant parameters and the index of time period distribution, basic infusion rate and the blood glucose fluctuation ideal range of insulin basis infusion amount, and the storage of Real-time Feedback blood glucose level data is organized in distribution on a time period; The time period of the insulin basis infusion amount that described algorithm unit is set according to the user distributes to divide the computation interval of Real-time Feedback blood glucose level data, and sets up the relational model of arbitrary moment patient blood glucose value and insulin basis infusion rate; Described simulation unit is on the relational model of described arbitrary moment patient blood glucose value and insulin basis infusion rate, the variable range of the basic infusion rate set according to the user is simulated when basic infusion rate change, sometime the section in the patient each the moment blood glucose value, and the ideal range of the blood glucose fluctuation set according to the user estimates and select best basic infusion rate value, thereby basic infusion rate is adjusted to optimized state and form the insulin pump in treatment scheme of individuation; If can't select best basic infusion rate value in section sometime, the time period that described simulation unit prompting user adjusts basic infusion amount distributes, in order to the blood glucose in each time period is controlled in ideal range.
According to an embodiment, in the aforementioned individual insulin treatment pump of the present invention, the time period of the insulin basis infusion amount that described algorithm unit is set according to the user distributes to divide the computation interval of Real-time Feedback blood glucose level data, and sets up as follows the relational model of arbitrary moment patient blood glucose value and insulin basis infusion rate:
If record altogether n blood glucose level data in certain period, at i constantly, the blood glucose value of human body is X
i=A
i– α * Uo
i+ C
i(i=1,2 ..., n)
Wherein, A
iFor human body at i basic blood glucose value constantly, not with every day the human body situation difference change; α is interior insulin of place time period in moment basis infusion rate for this reason, Uo
iFor the blood sugar lowering effect that the units of insulin infusion rate is carved at this moment, this effect is for the concrete patient in certain position, and the synchronization in every day is identical, C
iFor comprising other factors (events such as feed, activity) at interior random blood sugar undulating value.
At i+1 constantly, suppose C
I+1-C
iBe approximately 0,
X
i+1-X
i=A
i+1-A
i-α(Uo
i+1-Uo
i)。The identical i moment and the i+1 moment for another day, have
Y
I+1-Y
i=A
I+1-A
i-β (Uo
I+1-Uo
i), wherein, Y
iFor human body, at the i blood glucose value in the moment, this that β is the same day is insulin basis infusion rate in place time period constantly, for the β ≠ α calculated.Have:
Uo
I+1-Uo
i=[(X
I+1-X
i)-(Y
I+1-Y
i)]/(β-α), be designated as u
i
A
I+1-A
i=[β (X
I+1-X
i)-α (Y
I+1-Y
i)]/(β-α), be designated as a
i
Therefore, by the X in arbitrary moment
iCan obtain next blood glucose value X constantly
I+1With the pass of insulin basis infusion rate α, be: X
I+1=X
i+ ai-α u
i.(i=1,2,3…n-1)。
According to an embodiment, in the aforementioned individual insulin treatment pump of the present invention, described simulation unit is on the basis of above-mentioned model, the variable range of the basic infusion rate set according to the user is simulated when α changes, sometime the section in the patient each the moment blood glucose value, and the ideal range of the blood glucose fluctuation set according to the user estimates and select best α value, thereby basic infusion rate is adjusted to optimized state and form the insulin pump in treatment scheme of individuation.If can't select best α value, the time period that described simulation unit prompting user adjusts basic infusion amount distributes, in order to the blood glucose in each time period is controlled in ideal range.
According to an embodiment, in the aforementioned individual insulin treatment pump of the present invention, described insulin pump body by described communication module from described data processing module obtains the insulin pump in treatment scheme of individuation, control described infusion executor to patient's infusion of insulin according to this scheme, and complete demonstration and monitoring.
According to embodiment, the present invention also provides a kind of method that realizes optimizing basic infusion rate based on described insulinize pump, and the method comprises the following steps:
(1) user sets the initial insulin infusion scheme by described insulin pump body and comprises the basic infusion rate range of accommodation of time period distribution, day part of insulin basis infusion amount, relevant parameters and the index of blood glucose fluctuation ideal range, and starts CGMS monitoring patient's blood glucose;
(2) described insulin pump body is controlled described infusion executor to patient's infusion of insulin according to the initial insulin infusion scheme, and completes the functions such as demonstration, monitoring;
(3) described communication module and CGMS communication obtain dynamic blood glucose level data, with the communication of insulin pump body, obtain the basic infusion rate range of accommodation of time period distribution, day part that comprises insulin basis infusion amount, relevant parameters and the index of blood glucose fluctuation ideal range;
(4) described data processing module is stored, after calculating and emulation, basic infusion rate is adjusted to optimized state above data.
This realizes optimizing in the method for basic infusion rate, and the process that described data processing module is adjusted to optimal state by basic infusion rate comprises the following steps:
(21) described data storage cell storage comprises relevant parameters and the index of time period distribution, basic infusion rate and the blood glucose fluctuation ideal range of insulin basis infusion amount, and the storage of Real-time Feedback blood glucose level data is organized in distribution on a time period;
(22) time period of the insulin basis infusion amount that described algorithm unit is set according to the user distributes to divide the computation interval of Real-time Feedback blood glucose level data, and sets up the relational model of arbitrary moment patient blood glucose value and insulin basis infusion rate;
(23) described simulation unit is on the basis of above-mentioned model, the variable range of the basic infusion rate set according to the user is simulated when basic infusion rate change, sometime the section in the patient each the moment blood glucose value, and the ideal range of the blood glucose fluctuation set according to the user estimates and select best basic infusion rate value, thereby determine the basic infusion rate of the optimization based on patient's Real-time Feedback blood glucose level data.If can't select best α value, the time period that described simulation unit prompting user adjusts basic infusion amount distributes, in order to the blood glucose in each time period is controlled in ideal range.
With respect to prior art, insulin pump body of the present invention is accepted the initial insulin infusion scheme of user's setting and is comprised relevant parameters and the index of the time period distribution of insulin basis infusion amount, day part basis infusion rate range of accommodation, blood glucose fluctuation ideal range, and start to control described infusion executor to patient's infusion of insulin according to the initial insulin infusion scheme, and complete the functions such as demonstration, monitoring; Described communication module and CGMS communication obtain dynamic blood glucose level data, with the communication of insulin pump body, obtain the basic infusion rate range of accommodation of time period distribution, day part that comprises insulin basis infusion amount, relevant parameters and the index of blood glucose fluctuation ideal range; These data are after described data processing module storage, calculating and the emulation, and the basic infusion rate be optimized also forms the insulin pump in treatment scheme of individuation; After described insulin pump body obtains the insulin pump in treatment scheme of this individuation by described communication module, control described infusion executor to patient's infusion of insulin according to this scheme, and complete the functions such as demonstration, monitoring.In a word, adopted a kind of individual insulin treatment pump of this invention, Real-time Feedback blood glucose level data formation model that can be based on each patient self, and pass judgment on and optimize its basic infusion amount by the basic infusion rate that insulin is adjusted in simulation.
The accompanying drawing explanation
Fig. 1 is the individual insulin treatment pump structure schematic diagram according to the embodiment of the present invention.
Fig. 2 is the flow chart according to the simulation unit of the data processing module of the embodiment of the present invention basic infusion rate of optimization in section sometime.
The specific embodiment
In order more clearly to understand technology contents of the present invention, especially exemplified by following examples, be described with reference to the accompanying drawings.
In a kind of preferably embodiment of the present invention, the user is by button operation individual insulin treatment pump of the present invention.Communication module in Fig. 1 is connected with CGMS with the bluetooth communication agreement in this embodiment, with the data/address bus form, with the insulin pump body, is connected.
In this embodiment, the user sets initial insulin infusion scheme and relevant parameters and index in 4 left and right in afternoon of one day by the insulin pump body, includes but not limited to:
(1) the infusion of insulin scheme (hereinafter to be referred as option A) before 4 of that afternoons to 4 of the next afternoons is: short-acting insulin total amount 44
u/ d, foundation rate total amount 21
u, press six sections method infusions:
0.5
u/h 0.9
u/h 1.1
u/h 0.9
u/h 1.0
u/h 0.7
u/h
0:00———3:00———7:00———12:00———16:00———20:00———24:00
Wherein lower row distributed for the time period, the basis amount infusion rate that upper row is day part.
(2) 4 o'clock the next afternoons to the infusion of insulin scheme (hereinafter to be referred as option b) before 4 of the 3rd afternoons is: short-acting insulin total amount 45
u/ d, foundation rate total amount 23.4
u, press six sections method infusions:
0.6
u/h 1.0
u/h 1.2
u/h 1.0
u/h 1.1
u/h 0.8
u/h
0:00———3:00———7:00———12:00———16:00———20:00———24:00
(3) basis of 3:00~7:00 amount infusion rate adjustable extent is 0.7
u/ h~1.5
u/ h, according to the control target of " Guidelines for Management of Diabetes Mellitus was discussed version in 2010 " Type 2 Diabetes In China, this time period fasting glucose fluctuation ideal range is 3.9 – 7.2mmol/l (70 – 130mg/dl).
In this embodiment, after the user has set, start the CGMS monitoring human blood glucose in Fig. 1, and the insulin pump body started in Fig. 1 controls described infusion executor to patient's infusion of insulin according to option A, option b successively, and complete the functions such as demonstration, monitoring.。To the morning of the 3rd day during 7:00, the CGMS in Fig. 1 has had the blood glucose level data during the 3:00~7:00 of 2
In this embodiment, communication module in Fig. 1 obtains the blood glucose level data during this 3:00~7:00 on the two with the CGMS communication, with the communication of insulin pump body obtain the time period that comprises insulin basis infusion amount distribute, relevant parameters and the index of day part basis infusion rate range of accommodation, blood glucose fluctuation ideal range.Subsequently, the data processing module in Fig. 1 to above-mentioned data stored, calculating and emulation, the basic infusion rate be optimized.Take 3:00~7:00 time period is example, optimization around here basic infusion rate be 1.3
u/ h.Similarly, data processing module obtain each time period optimization basic infusion rate, and the insulin pump in treatment scheme (hereinafter to be referred as scheme C) that forms individuation is: short-acting insulin total amount 44
u/ d, foundation rate total amount 23.5
u, press six sections method infusions:
0.7
u/h 1.2
u/h 1.0
u/h 0.9
u/h 1.4
u/h 0.6
u/h
0:00———3:00———7:00———12:00———16:00———20:00———24:00
In this embodiment, insulin pump body in Fig. 1 obtains the insulin pump in treatment scheme of this individuation by the communication module in Fig. 1, since the 4:00 in afternoon of the 3rd day (the 3rd 24 hours start) according to the infusion executor of scheme C control figure 1 to patient's infusion of insulin, and complete the functions such as demonstration, monitoring.
In this embodiment, the data processing module in Fig. 1 is comprised of data storage cell, algorithm unit and simulation unit.Data storage cell storage in Fig. 1 comprises relevant parameters and the index of time period distribution, basic infusion rate and the blood glucose fluctuation ideal range of insulin basis infusion amount, and the storage of Real-time Feedback blood glucose level data is organized in distribution on a time period.If an average blood sugar value of every 10 minutes of CGMS record,, between the 3:00~7:00 of second day and the 3rd day, respectively have 24 data.Data storage cell in Fig. 1 is about to it and is recorded at the same time in section, and the data of obtaining are as follows:
In this embodiment, the time period of the insulin basis infusion amount that the algorithm unit in Fig. 1 is set according to the user distributes to divide the computation interval of Real-time Feedback blood glucose level data, and sets up the relational model of arbitrary moment patient blood glucose value and insulin basis infusion rate.With above-mentioned data instance, the modeling method by before this, for 3:00~7:00 time period, can obtain X
I+1=X
i+ ai-α u
i.(i=1,2,3 ... n-1), X
iFor i blood glucose value constantly, α is basic infusion rate.Ai and ui meet:
Constantly | ai(mmol/L) | ui(mmol·h/L·u) |
1 | -0.216 | -0.019 |
2 | 0.151 | -0.043 |
3 | 0.091 | 0.026 |
4 | -0.105 | -0.026 |
5 | 0.034 | 0.015 |
6 | 0.015 | -0.007 |
7 | -0.156 | 0.029 |
8 | 0.004 | -0.048 |
9 | 0.129 | -0.014 |
10 | -0.051 | 0.043 |
11 | -0.049 | -0.001 |
12 | -0.005 | 0.048 |
13 | 0.055 | -0.037 |
14 | -0.015 | -0.039 |
15 | 0.099 | -0.016 |
16 | -0.105 | 0.022 |
17 | 0.118 | -0.003 |
18 | -0.155 | 0.058 |
19 | -0.166 | 0.011 |
20 | 0.057 | -0.017 |
21 | 0.165 | -0.063 |
22 | -0.283 | -0.004 |
23 | 0.066 | 0.000 |
In this embodiment, the simulation unit in Fig. 1, on the basis of above-mentioned model, is optimized basic infusion rate according to the flow process of Fig. 2.Still take 3:00~7:00 time period is example.At first, simulation unit according to user base infusion rate scope obtain for the simulation basic infusion rate set Α={ 0.7,0.8,0.9,1.0,1.1,1.2,1.3,1.4,1.5}, make j=1 subsequently, is equivalent to α=0.7u/h substitution X
I+1=X
i+ ai-α u
i, emulation obtains the interior blood glucose value since the 2nd moment of this time period and is: 7.24,7.42,7.50,7.41,7.43,7.45,7.28,7.31,7.45,7.37,7.32,7.29,7.37,7.38,7.49,7.37,7.49,7.29,7.12,7.19,7.40,7.12 7.18mmol/L, not in the desirable fluctuation range of blood glucose (3.9~7.2mmol/L), therefore directly enter the next round simulation.After this simulation unit is successively by α=0.8~1.5u/h substitution X
I+1=X
i+ ai-α u
i, and simulate, pass judgment on, find when α=1.2
uDuring/h, in this time period, since the blood glucose value in the 2nd moment, be 6.91,7.11,7.17,7.10,7.11,7.13,6.94,7.01,7.15,7.05,7.00,6.94,7.04,7.07,7.19,7.06,7.18,6.95,6.78,6.85,7.09,6.81,6.88, in the desirable fluctuation range of blood glucose, therefore by 1.2
u/ h deposits A ' set in.After this find α=1.3,1.4 and 1.5
uDuring/h, blood glucose value is also in desirable fluctuation range, therefore final A ' set has 1.2
u/ h, 1.3
u/ h, 1.4
u/ h, 1.5
u4 elements such as/h, simulation unit selects wherein minimum 1.2
u/ h is as the basic infusion rate after optimizing, and in conjunction with the basic infusion rate after the optimization of other times section, the insulin pump in treatment scheme that finally forms individuation is: short-acting insulin total amount 44
u/ d, foundation rate total amount 23.5
u, press six sections method infusions:
0.7
u/h 1.2
u/h 1.0
u/h 0.9
u/h 1.4
u/h 0.6
u/h
0:00———3:00———7:00———12:00———16:00———20:00———24:00
Adopt the method based on the basic infusion rate of described insulinize pump realization optimization of this embodiment, comprise the following steps:
(21) user sets initial insulin infusion scheme and relevant parameters and index by the insulin pump body in Fig. 1 and is:
(31) the infusion of insulin scheme (hereinafter to be referred as option A) in first 24 hours is: short-acting insulin total amount 44
u/ d, foundation rate total amount 21
u, press six sections method infusions:
0.5
u/h 0.9
u/h 1.1
u/h 0.9
u/h 1.0
u/h 0.7
u/h
0:00———3:00———7:00———12:00———16:00———20:00———24:00
Wherein lower row distributed for the time period, the basis amount infusion rate that upper row is day part.
(32) second infusion of insulin schemes (hereinafter to be referred as option b) in 24 hours are: short-acting insulin total amount 45
u/ d, foundation rate total amount 23.4
u, press six sections method infusions:
0.6
u/h 1.0
u/h 1.2
u/h 1.0
u/h 1.1
u/h 0.8
u/h
0:00———3:00———7:00———12:00———16:00———20:00———24:00
(33) basis of 3:00~7:00 amount infusion rate adjustable extent is 0.7
u/ h~1.5
u/ h, the blood glucose fluctuation ideal range is 3.9~7.2mmol/L.
(22) user starts the blood glucose of the CGMS monitoring patient in Fig. 1;
(23) the insulin pump body in Fig. 1 is controlled described infusion executor to patient's infusion of insulin according to option A, option b successively, and completes the functions such as demonstration, monitoring;
(24) communication module in Fig. 1 and CGMS communication obtain dynamic blood glucose level data, with the communication of insulin pump body, obtain the basic infusion rate range of accommodation of time period distribution, day part that comprises insulin basis infusion amount, relevant parameters and the index of blood glucose fluctuation ideal range;
(25) data processing module in Fig. 1 is stored, after calculating and emulation, basic infusion rate is adjusted to optimized state above data;
Adopt the realization of this embodiment to optimize in the method for basic infusion rate, the process of basic infusion rate being adjusted to optimal state comprises the following steps:
(41) storage of the data storage cell in Fig. 1 comprises relevant parameters and the index of time period distribution, basic infusion rate and the blood glucose fluctuation ideal range of insulin basis infusion amount, and the storage of Real-time Feedback blood glucose level data is organized in distribution on a time period;
(42) time period of the insulin basis infusion amount that the algorithm unit in Fig. 1 is set according to the user distributes to divide the computation interval of Real-time Feedback blood glucose level data, and sets up the relational model of arbitrary moment patient blood glucose value and insulin basis infusion rate;
(43) simulation unit in Fig. 1 is on the basis of above-mentioned model, according to the flow chart shown in Fig. 2, the variable range of the basic infusion rate set according to the user is simulated when basic infusion rate change, sometime the section in the patient each the moment blood glucose value, and the ideal range of the blood glucose fluctuation set according to the user estimates and select best basic infusion rate value, thereby determine the basic infusion rate of the optimization based on patient's Real-time Feedback blood glucose level data.If can't select best basic infusion rate value in section sometime, the time period that described simulation unit prompting user adjusts basic infusion amount distributes, in order to the blood glucose in each time period is controlled in ideal range.
In this description, the present invention is described with reference to its specific embodiment.But, still can make various modifications and conversion obviously and not deviate from the spirit and scope of the present invention.Therefore, description and accompanying drawing are regarded in an illustrative, rather than a restrictive.After the content of having read the present invention's record, those skilled in the art can make various changes or modifications the present invention, and these equivalences change and modification falls into the scope of the claims in the present invention equally.
Claims (7)
1. an individual insulin treatment pump, it is characterized in that, comprise insulin pump body, communication module, data processing module and infusion executor, described insulin pump body is accepted the therapeutic scheme that described data processing module draws, and according to the described infusion executor of control infusion of insulin; Described communication module forms therapeutic scheme from dynamic blood sugar monitoring system CGMS and described insulin pump ontology acquisition data for described data processing module.
2. individual insulin treatment pump according to claim 1, is characterized in that, described data processing module comprises data storage cell, algorithm unit and simulation unit, wherein:
Described data storage cell storage comprises relevant parameters and the index of time period distribution, basic infusion rate and the blood glucose fluctuation ideal range of insulin basis infusion amount, and the storage of Real-time Feedback blood glucose level data is organized in distribution on a time period;
The time period of the insulin basis infusion amount that described algorithm unit is set according to the user distributes to divide the computation interval of Real-time Feedback blood glucose level data, and sets up the relational model of arbitrary moment patient blood glucose value and insulin basis infusion rate;
Described simulation unit is on the relational model of described arbitrary moment patient blood glucose value and insulin basis infusion rate, the variable range of the basic infusion rate set according to the user is simulated when basic infusion rate change, sometime the section in the patient each the moment blood glucose value, and the ideal range of the blood glucose fluctuation set according to the user estimates and select best basic infusion rate value, thereby basic infusion rate is adjusted to optimized state and form the insulin pump in treatment scheme of individuation; If can't select best basic infusion rate value in section sometime, the time period that described simulation unit prompting user adjusts basic infusion amount distributes, in order to the blood glucose in each time period is controlled in ideal range.
3. individual insulin treatment pump according to claim 2, is characterized in that, described algorithm unit is set up the relational model of arbitrary moment patient blood glucose value and insulin basis infusion rate as follows:
If record altogether n blood glucose level data in certain period, at i constantly, the blood glucose value of human body is X
i=A
i– α * Uo
i+ C
i(i=1,2 ..., n)
Wherein, A
iFor human body at i basic blood glucose value constantly, not with every day the human body situation difference change; α is interior insulin of place time period in moment basis infusion rate for this reason, Uo
iFor the blood sugar lowering effect that the units of insulin infusion rate is carved at this moment, this effect is for the concrete patient in certain position, and the synchronization in every day is identical, C
iFor comprising the factors such as feed, activity at interior random blood sugar undulating value;
At i+1 constantly, suppose C
I+1-C
iBe approximately 0,
X
I+1-X
i=A
I+1-A
i-α (Uo
I+1-Uo
i), the identical i moment and the i+1 moment for another day, have
Y
I+1-Y
i=A
I+1-A
i-β (Uo
I+1-Uo
i), wherein, Y
iFor human body, at the i blood glucose value in the moment, this that β is the same day is insulin basis infusion rate in place time period constantly, and the β ≠ α for calculating has:
Uo
I+1-Uo
i=[(X
I+1-X
i)-(Y
I+1-Y
i)]/(β-α), be designated as u
i
A
I+1-A
i=[β (X
I+1-X
i)-α (Y
I+1-Y
i)]/(β-α), be designated as a
i
Therefore, by the X in arbitrary moment
iCan obtain next blood glucose value X constantly
I+1With the pass of insulin basis infusion rate α, be:
X
i+1=X
i+ai-αu
i。(i=1,2,3…n-1)。
4. individual insulin treatment pump according to claim 3, it is characterized in that, described simulation unit is on the basis of above-mentioned model, the variable range of the basic infusion rate set according to the user is simulated when α changes, sometime the section in the patient each the moment blood glucose value, and the ideal range of the blood glucose fluctuation set according to the user estimates and select best α value, thereby basic infusion rate is adjusted to optimized state and form the insulin pump in treatment scheme of individuation; If can't select best α value, the time period that described simulation unit prompting user adjusts basic infusion amount distributes, in order to the blood glucose in each time period is controlled in ideal range.
5. according to any one described individual insulin treatment pump of claim 1-4, it is characterized in that, described insulin pump body by described communication module from described data processing module obtains the insulin pump in treatment scheme of individuation, control described infusion executor to patient's infusion of insulin according to this scheme, and complete demonstration and monitoring.
6. realize based on any one described insulinize pump of claim 1-5 the method that basic infusion rate is optimized for one kind, it is characterized in that, described method comprises the following steps:
(1) user sets the initial insulin infusion scheme by described insulin pump body and comprises the basic infusion rate range of accommodation of time period distribution, day part of insulin basis infusion amount, relevant parameters and the index of blood glucose fluctuation ideal range, and starts dynamic blood sugar monitoring system CGMS monitoring patient's blood glucose;
(2) described insulin pump body is controlled described infusion executor to patient's infusion of insulin according to the initial insulin infusion scheme, and completes demonstration and monitoring;
(3) described communication module and dynamic blood sugar monitoring system CGMS communication obtain dynamic blood glucose level data, with the communication of insulin pump body, obtain the basic infusion rate range of accommodation of time period distribution, day part that comprises insulin basis infusion amount, relevant parameters and the index of blood glucose fluctuation ideal range;
(4) described data processing module is stored, after calculating and emulation, basic infusion rate is adjusted to optimized state above data.
7. the method that realizes basic infusion rate optimization based on the insulinize pump according to claim 6, is characterized in that, the process that described data processing module is adjusted to optimal state by basic infusion rate comprises the following steps:
(21) described data storage cell storage comprises relevant parameters and the index of time period distribution, basic infusion rate and the blood glucose fluctuation ideal range of insulin basis infusion amount, and the storage of Real-time Feedback blood glucose level data is organized in distribution on a time period;
(22) time period of the insulin basis infusion amount that described algorithm unit is set according to the user distributes to divide the computation interval of Real-time Feedback blood glucose level data, and sets up the relational model of arbitrary moment patient blood glucose value and insulin basis infusion rate;
(23) described simulation unit is on the basis of (22) described relational model, the variable range of the basic infusion rate set according to the user is simulated when basic infusion rate change, sometime the section in the patient each the moment blood glucose value, and the ideal range of the blood glucose fluctuation set according to the user estimates and select best basic infusion rate value, thereby determine the basic infusion rate of the optimization based on patient's Real-time Feedback blood glucose level data; If can't select best basic infusion rate value in section sometime, the time period that described simulation unit prompting user adjusts basic infusion amount distributes, in order to the blood glucose in each time period is controlled in ideal range.
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